ESC PINNACLE 2218-00-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295099512), received between Oct 6, 2017 and Apr 29, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  DURING A HIP SURGERY, THE DR WAS PUTTING THE RETAINING RING ON AN ES CONSTRAINED LINER WHEN THE HANDLE OF THE RETAINING RING INSERTER BROKE. HE WAS STILL ABLE TO USE THE INSERTER TO COMPLETE THE CASE AND THERE WAS NO DELAY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, IF YES, NUMBER OF MINUTES: 0. ACTION TAKEN WHEN EVENT OCCURRED? THE SURGEON USED TO INSERTER TO PUT THE RETAINING RING ON THE CONSTRAINED LINER, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035163 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT HANDLE SNAPPED WHILE IMPACTING LOCKING RING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117249 ↗
• MalfunctionAug 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AN UNKNOWN PRODUCT DEFICIENCY WAS NOTICED DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22837463 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENT WAS BROKEN BY SURGEON WHILE IMPACTING WITH MALLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782585 ↗
• MalfunctionJul 7, 2025Break; Crack; Break; Crack

  IT WAS REPORTED WHILE PUSHING THE PINNACLE CONSTRAINED RING HANDLE INTO THE ACETABULUM TO SEAT THE RING, THE HANDLE CRACKED AND BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412418 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NEEDED TO REVISE A SROM HEAD MATED WITH ANOTHER MEDICAL COMPANY'S MDM DUE TO INCOMPATIBILITY RESULTING IN LOOSENESS OF THE HEAD CONSTRUCT. MDM CONSTRUCT WAS EXCHANGED FOR A 32 METAL SROM HEAD AND A 32MM COMPETITOR LIPPED LINER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED AREA: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22026177 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE INSERTION OF THE WHITE HANDLE TO LOCK THE CONSTRAINED LINER METAL BEVEL INTO PLACE THE WHITE HANDLE FROM MID-JUNCTION SNAPPED. SURGEON WENT TO LEVER THE HANDLE AND ALIGN THE HANDLE INTO PLACE AND A CLEAN BREAK ON THE WHITE HANDLE OCCURRED. THEY WERE ABLE TO FINISH THE CASE WITH NO DELAYS.

  Patient problems: Insufficient Information

  MAUDE report 22012779 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT SURGEON WAS PUSHING ON THE HANDLE TO SEAT THE LOCKING RING AND THE HANDLE SNAPPED AT THE FIRST INDENTATION OF THE HANDLE. ALL PIECES WERE RECOVERED AND NO HARM WAS DONE TO THE PATIENT. DID NOT ADD ANY TIME TO THE SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962833 ↗
• MalfunctionNov 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING THE SURGERY. UPON MANUFACTURERS INVESTIGATION IT WAS IDENTIFIED THAT THE WHITE PLASTIC RADEL BROKEN FROM THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 20622093 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT THE RING INSERTION HANDLE BROKE FROM ENHANCED STABILITY CONSTRAINED TRAY DURING CASE ON (B)(6) 2024. IT WAS A CONSTRAINED LINER RING INSERTER THAT BROKE DURING THE HANDLE AT THE HANDLE. NO FRAGMENTS WERE RETAINED IN THE PATIENT. BROKE INTO TWO PIECES. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928868 ↗
• MalfunctionFeb 7, 2024Break; Break

  DURING OPERATION, THE WHITE HANDLE SNAPPED OFF OF THE RING INSERTED. THE SURGEON WAS ABLE TO SECURE THE RING WITH THE BROKEN HANDLE. THERE WERE NO SURGICAL DELAYS OR NEGATIVE CONSEQUENCES. IT WAS DISCARDED AFTER THE SURGERY. NO FUTURE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658300 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SALES REP PUT THESE INSTRUMENTS TOGETHER TO TEST BEFORE USING AND COULD NOT TAKE APART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432770 ↗
• MalfunctionFeb 13, 2023Break; Break

  IT WAS REPORTED THAT THE WHITE HANDLE BROKE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367693 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON STRUCK THE HANDLE WHERE IT SAID "DO NOT STRIKE" AND IT BROKE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939711 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT WHILE UTILIZING THE ESC RING INSERTER, THE WHITE PLASTIC ASPECT OF THE INSERTER HANDLE BROKE, ESSENTIALLY IN HALF, WHILE BEING STRUCK WITH A MALLET. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239616 ↗
• MalfunctionJan 23, 2019Break; Break

  THE WHITE HANDLE BROKE IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270903 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS IMPACTED AND SHATTERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235356 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE PINNACLE ESC CONSTRAINED RING HANDLE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121189 ↗
• MalfunctionOct 6, 2017Break; Break

  IT WAS REPORTED THAT THE WHITE PART OF THE HANDLE THAT WAS USED TO IMPACT THE RING AROUND THE CONSTRAINED LINER BROKE OFF IN THE MIDDLE.

  Patient problems: No Information

  MAUDE report 6921838 ↗